Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.

Launched by VITEBSK REGIONAL CLINICAL CANCER CENTRE · Dec 30, 2024

Keywords

ClinConnect Summary

This is a single-center, open-label study. After meeting the eligibility criteria and enrolling in the trial, patients will take Ibrutinib for 3 months up to Day -1. Leukapheresis for the collection of autologous lymphocytes will take place 2-3 weeks before Day 0. Once the cells have been manufactured, patients will proceed to lymphodepleting chemotherapy with cyclophosphamide and fludarabine from Days -5 to -3, followed by the infusion of anti-CD19-4-1BB-CD3z CAR T-cells at two fixed dose levels: DL1 (50 x 10\^6 cells) and DL2 (150 x 10\^6 cells), concomitantly with Lenalidomide intake. Le...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented CD19+ CLL or SLL
• • Patients must have failed at least 1 prior regimen
• * Patients must be currently receiving ibrutinib for at least 3 months prior to enrollment in the study and:
• • Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
• • ECOG Performance status 0 or 1
• • 18 years of age and older
• * Adequate organ system function including:
• • Creatinine \< 1.6 mg/dl ALT/AST \< 3x upper limit of normal Total Bilirubin \<2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.
• • Have no active GVHD and require no immunosuppression
• • Are more than 6 months from transplant
• • No contraindications for leukapheresis
• • Left Ventricular Ejection fraction \>50%
• • Gives informed consent
• Exclusion Criteria:
• • CLL patients with known or suspected transformed disease (i.e. Richter's transformation).
• • Pregnant or lactating women.
• • Uncontrolled active infection.
• • Active hepatitis B or hepatitis C infection.
• • Concurrent use of systemic steroids or chronic use of immunosuppressant medications.
• • Any uncontrolled active medical disorder
• • HIV infection.
• • Patients with active CNS involvement with malignancy.
• • Class III/IV cardiovascular disability according to the New York Heart Association Classification.
• • Subjects with clinically apparent arrhythmia or arrhythmias who are not stable